MAUDE Adverse Event Report: IMPLANT DIRECT LLC SWISHPLUS® IMPLANT; DENTAL IMPLANT

Model Number	924116
Medical Device Problem Code	Device Misassembled During Manufacturing /Shipping (2912)
Health Effect - Clinical Code	Not Applicable (3189)
Type of Reportable Event	Malfunction
Event or Problem Description
The implant extender is packaged upside down.This may result in the extender being placed on the implant incorrectly.

• Brand Name: SWISHPLUS® IMPLANT
• Common Device Name: DENTAL IMPLANT
• Manufacturer (Section D): IMPLANT DIRECT LLC; 3050 e hillcrest dr.; thousand oaks CA 91362
• MDR Report Key: 7125688
• Report Number: 3001617766-2017-00042
• Device Sequence Number: 1079565
• Product Code: DZE
• UDI-Device Identifier: 10841307106173
• UDI-Public: 10841307106173
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K081396
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,foreign
• Initial Reporter Occupation: Other
• Remedial Action: Recall,Notification,Modification/Adjustment
• Type of Report: Initial
• Report Date (Section B): 11/20/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Other
• Device Expiration Date: 11/16/2020
• Device Model Number: 924116
• Device Catalogue Number: 924116
• Device Lot Number: 70543
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/20/2017
• Initial Report FDA Received Date: 12/18/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention